NCT01994447 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Davis DP, Poste JC, Kelly D
The UCSD Research Associate Program: a recipe for successfully integrating undergraduates with emergency medicine research. J Emerg Med. 2005 Jan;28(1):89-93.
Flory J, Emanuel E
Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-601. Review.
Hollander JE, Singer AJ
An innovative strategy for conducting clinical research: the academic associate program. Acad Emerg Med. 2002 Feb;9(2):134-7.
Miller CK, O'Donnell DC, Searight HR, Barbarash RA
The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects. Pharmacotherapy. 1996 Sep-Oct;16(5):872-8.
Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ
Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003717. doi: 10.1002/14651858.CD003717.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;5:CD003717.
Segal S, Lloyd T, Houts PS, Stillman PL, Jungas RL, Greer RB 3rd
The association between students' research involvement in medical school and their postgraduate medical activities. Acad Med. 1990 Aug;65(8):530-3.
Tait AR, Voepel-Lewis T, Malviya S
Do they understand? (part I): parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology. 2003 Mar;98(3):603-8.

"Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)

Details for clinical trial NCT01994447

Clinical trial NCT01994447 - References